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Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites

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ClinicalTrials.gov Identifier: NCT02643680
Recruitment Status : Recruiting
First Posted : December 31, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University

Brief Summary:
  1. The wound healing time of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  2. The wound quality of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  3. The amounts of STSG donor site infection which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should not be more than Bactigras®.
  4. The pain level of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  5. Adverse events which are occurred from the novel biocellulose wound dressing containing silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported, if they occur.

Condition or disease Intervention/treatment Phase
Wound Disorder of Skin Donor Site Device: The novel biocellulose wound dressing Device: Bactigras Phase 2

Detailed Description:
The goals of STSG donor site treatment are to accelerate wound healing, prevent infection, reduce pain, and maintain an optimal environment healing promotion. Biocellulose is an ultrafine fiber structure that can hold a large amount of water and has a cooling effect that decreases pain without causing an allergic reaction or irritation.Silk sericin (SS) can activate the growth of fibroblast cells which promote collagen type I production and accelerated wound healing without toxicity . Polyhexamethylene biguanide (PHMB) is a broad spectrum antimicrobial agent with high efficacy and low toxicity. Therefore, the combination of silk sericin and PHMB in biocellulose dressings would benefit STSG donor site wound treatment. The purpose of this study is to investigate the clinical efficacy of this dressing for STSG donor site wound treatment compared with Bactigras® (chlorhexidine acetate 0.5% in white soft paraffin), which is the standard dressing for this type of wound at King Chulalongkorn Memorial Hospital, by monitoring the time required for complete re-epithelization, wound quality, the rate of infection, pain, and the adverse events from December 2015 to November 2016. Thirty two subjects (more than 18 years) with STSG donor site at thigh will be recruited in this study. Block randomization will be used for separation half of eligible wound to cover with novel biocellulose wound dressing containing silk sericin and PHMB or Bactigras®. Wound healing time is the day that the dressing detaches by itself with no exudate and air contacted pain. Wound quality at 1,3,and 6 months will be measured in terms of erythema level, melanin level, transepidermal water loss by using Cutometer® and scar quality (vancouver scar scale). Sign of infection, pain (VAS score), hepatic and renal function will also be collected.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of the Novel Biocellulose Wound Dressing Containing Silk Sericin and Polyhexamethylene Biguanide for Split-thickness Skin Graft Donor Sites
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The novel biocellulose wound dressing Device: The novel biocellulose wound dressing
The novel biocellulose dressing will used as a primary dressing at one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.
Other Name: Biocellulose dressing containing silk sericin and PHMB

Active Comparator: Bactigras Device: Bactigras
Bactigras will used as a primary dressing at another one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.
Other Name: Chlorhexidine acetate 0.5% in white soft paraffin




Primary Outcome Measures :
  1. Healing time [ Time Frame: 6 months ]
    The day that the dressing detaches by itself with no exudate and air contacted pain


Secondary Outcome Measures :
  1. Erythema and melanin level of wound [ Time Frame: 1 year ]
    Erythema and melanin level by using Cutometer® with mexameter mode (Courage+Khazaka electronic GmbH, Germany) at healing day, 1, 3,and 6 months after healing

  2. Transepidermal water loss of wound [ Time Frame: 1 year ]
    Transepidermal water loss by using Cutometer® with tewameter mode (Courage+Khazaka electronic GmbH, Germany) at healing day, 1, 3,and 6 months after healing

  3. Wound scar formation [ Time Frame: 1 year ]
    Vancouver scar scale at healing day, 1, 3,and 6 months after healing

  4. Signs of infection [ Time Frame: 1 year ]
    Signs of infection: swelling, redness, bad odor, purulent discharge everyday

  5. Swab test of infection wound [ Time Frame: 1 year ]
    Swab evaluation when signs of infection observes

  6. Pain score [ Time Frame: 6 months ]
    Visual analogue scale

  7. Adverse events [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have STSG donor site wounds on the thigh
  • Age more than 18 years old
  • Signed consent form

Exclusion Criteria:

  • Systemic infection
  • Known allergy or hypersensitivity reaction to silk sericin , PHMB, or chlorhexidine acetate
  • Known skin diseases
  • Known immunocompromised diseases
  • Known mental defect or schizophrenia
  • Pregnancy or lactation
  • Not follow all procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643680


Contacts
Contact: Pornanong Aramwit, Ph.D +66899217255 aramwit@gmail.com

Locations
Thailand
Chulalongkorn Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Pornanong Aramwit, Ph.D.    +66-89-9217255    aramwit@gmail.com   
Principal Investigator: Pornanong Aramwit, Ph.D.         
Sponsors and Collaborators
Chulalongkorn University
Investigators
Principal Investigator: Pornanong Aramwit, Ph.D Chulalongkorn University

Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02643680     History of Changes
Other Study ID Numbers: Med CU IRB 242/58
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University:
Biocellulose
Silk sericin
Polyhexamethylene biguanide
Split thickness skin graft donor site

Additional relevant MeSH terms:
Wounds and Injuries
Skin Diseases
Chlorhexidine
Polihexanide
Biguanides
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Hypoglycemic Agents
Physiological Effects of Drugs